Ultrasound-guided Abdominal Wall Nerve Blockade in Laparoscopic Surgery for Acute Appendicitis. (BD-TAP APP)
Acute appendicitis is a common disease and usually occurs within the ages of 10-30 years old." Ten percent of the population will get this disease during a lifetime." At Bispebjerg hospital it is one of the most common acute surgeries performed. Though at Bispebjerg hospital the surgery is only performed on adults as there is no pediatric ward. The surgical technique is primarily laparoscopic surgery, where the patients have their appendix removed while in general anaesthesia. During the last three years Bispebjerg hospital has had an average of 287 patients per year undergoing laparoscopic surgery. From January to the September 2012 a total of 211 patients have had the operation, with 29% having the operation performed during daytime, 48% in the evening and 22% at night. Open appendectomy is only performed in cases where laparoscopic surgery is impossible, this is often due to adhesions, scar tissue from former abdominal surgery or peritonitis. The scars from laparoscopic surgery are usually smaller than that from an open appendectomy, but it gives the patient three smaller scars divided on three abdominal quadrants instead of one larger scar on one quadrant.
The investigators want to conduct a clinical trial with fifty six patients undergoing laparoscopic surgery due to acute appendicitis. The investigators want to find out if it is possible to improve the post-operative pain management within this very large group of patients undergoing acute surgery. In detail, the investigators wish to explore whether the use of the BD-TAP blockade in the abdominal wall on patients undergoing laparoscopic surgery due to acute appendicitis, can anesthetize the patients completely or partially, so they can avoid morphine intake completely or partially during the post-operative phase (12-24 hours). The research project will be a randomized, double-blinded, controlled clinical trial.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Optimal Postoperative Pain Management by Ultrasound-guided Abdominal Wall Nerve Blockade in Laparoscopic Surgery for Acute Appendicitis - a Randomised Controlled Trial.|
- Area under the curve (AUC), 0-12 hours, numerical rating score-pain-(NRS)0-10 [ Time Frame: 0-12 hours postoperatively ] [ Designated as safety issue: No ]Pain score (NRS) assessed when sitting up 0-12 hours postoperatively. AUC is calculated over a time frame of 0-12 hours.
- Area under the curve (AUC), 0-12 hours postoperatively, numerical rating score - pain-(NRS) 0-10 [ Time Frame: 0-12 hours postoperatively ] [ Designated as safety issue: No ]NRS 0-10 is assessed 0-12 hours postoperatively. AUC is calculated 0-12 hours postoperatively.
- Morphine consumption postoperatively [ Time Frame: 0-12 hours postoperatively ] [ Designated as safety issue: No ]Morphine consumption postoperatively registered from the patient controlled analgesia (PCA) pump.
- Length of stay (LOS) in the postanesthesia care unit (PACU) [ Time Frame: Time from arrival in PACU to time of departure (measured in minutes) ] [ Designated as safety issue: No ]
- Side effects related to morphine consumption [ Time Frame: 0-12 hours postoperatively ] [ Designated as safety issue: No ]Side effects recorded: nausea and vomiting
- Time to first mobilisation 0-12 hours postoperatively [ Time Frame: 0-12 hours postoperatively ] [ Designated as safety issue: No ]
|Study Start Date:||June 2013|
|Study Completion Date:||December 2013|
|Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Active Comparator: Active abdominal wall block
60ml ropivacaine 0.375% single shot
Placebo Comparator: Placebo abdominal wall block
60ml saline 9% single shot
|Drug: Saline 9%|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01825863
|Department of anaesthesiology, Bispebjerg Hospital|
|Copenhagen, Denmark, 2400 NV|
|Principal Investigator:||Katrine Tanggaard, research year fellow||Bispebjerg Hospital|